Serious Game for Congenital Heart Disease

Overseen By Rebecca Delaney, PhD

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: University of Utah

Disqualifiers: Visual, cognitive impairment

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new video game designed to help teenagers with congenital heart disease (CHD) manage their health independently. The game, called a "serious game for transition readiness," aims to teach skills such as communicating with doctors, understanding medical information, and managing appointments and medications. Researchers aim to assess the game's ease of use, helpfulness, and impact on communication during doctor visits. Teens with CHD, their parents, and their doctors can participate, though those with significant vision or cognitive challenges might not be suitable. As an unphased trial, this study offers participants a unique opportunity to contribute to innovative educational tools that could empower teens with CHD.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It seems focused on evaluating a video game for managing health, so it's unlikely to require changes to your medication routine.

What prior data suggests that this game is safe for adolescents with congenital heart disease?

Research has shown that serious games, like the one tested in this study, can help individuals with congenital heart disease (CHD) better manage their health. These games teach crucial skills, such as communicating with doctors and understanding medical information.

Regarding safety, no negative effects have been reported from using these types of games. Since this study involves a video game, it is generally considered safe for participants. The main goal is to assess how well the game improves skills and confidence in managing heart care, rather than focusing on physical safety issues.

Overall, the game aims to ease and enhance the transition to adult care for teenagers with CHD. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the serious game for congenital heart disease because it offers a novel approach to building transition readiness skills for young patients. Unlike traditional educational programs or counseling sessions, this game uses interactive and engaging gameplay to help patients understand and manage their condition. This can make learning more appealing and effective, especially for younger individuals who might find conventional methods less engaging. By fostering proactive management skills, the game aims to empower patients and improve their long-term health outcomes as they transition from pediatric to adult care.

What evidence suggests that this serious game is effective for congenital heart disease?

Research has shown that digital tools like video games can help teenagers with congenital heart disease (CHD) prepare to manage their health. This trial will evaluate a serious game designed to build transition readiness skills for young people moving to adult care. These skills include communicating with doctors and managing appointments and medications. Early results from other studies suggest that game technology in this education effectively engages young patients. This method aims to boost their confidence and prepare them to take charge of their own health care. ^{1 2 5 6 7}

Are You a Good Fit for This Trial?

This trial is for adolescents with congenital heart disease who are learning to manage their health care independently. It's designed to help them communicate better with doctors, understand medical info, and handle appointments and meds on their own.

Inclusion Criteria

Patient with congenital heart disease, their parent, and their clinician

Exclusion Criteria

I do not have severe vision or thinking problems that would stop me from participating.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants engage with the serious game designed to build transition readiness skills

1 month

Game interaction and feedback collection

Follow-up

Participants are monitored for retention and acceptability of the game

1.5 months

What Are the Treatments Tested in This Trial?

Interventions

• Serious game for transition readiness

Trial Overview The study tests a new video game that teaches transition readiness skills to teens with CHD. The goal is to see if the game makes it easier for them to take charge of their health as they move towards adult care.

How Is the Trial Designed?

Group I: Serious Game Experimental Treatment 1 Intervention

Receive serious game to build transition readiness skills

Who Is Running the Clinical Trial?

University of Utah

Lead Sponsor

Trials

1,169

Recruited

1,623,000+

American Heart Association

Collaborator

Trials

352

Recruited

6,196,000+

National Center for Advancing Translational Sciences (NCATS)

Collaborator

Trials

394

Recruited

404,000+

Citations

1. ahajournals.org ahajournals.org/doi/10.1161/JAHA.125.043809

Are Patients Game? Investigating the Role of ... We aimed to identify gaps in transition readiness skills and knowledge, as well as adolescents' and young adults' interest in games and game ...

2. clinicaltrials.gov clinicaltrials.gov/ct2/show/NCT07042334

Aim 3: Pilot Study of a Serious Game to Promote Transition ... This study involves testing a new video game designed to support adolescents with congenital heart disease (CHD) in preparing to manage their health ...

3. ahajournals.org ahajournals.org/doi/pdf/10.1161/JAHA.125.043809?download=true

Are Patients Game? Investigating the Role of ... We aimed to identify gaps in transition readiness skills and knowledge, as well as adoles- cents' and young adults' interest in games and game features for CHD ...

4. researchgate.net researchgate.net/publication/394161813_Digital_interventions_for_facilitating_the_transition_of_young_people_with_congenital_heart_disease_CHD_to_adult_healthcare_a_systematic_review

Digital interventions for facilitating the transition of young ... PDF | Background: Transitioning to adult care presents significant challenges for young people with congenital heart disease (CHD), ...

5. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/41120822/

Are Patients Game? Investigating the Role of ... Are Patients Game? Investigating the Role of Game Technology in Transition Education for Congenital Heart Disease.

6. ahajournals.org ahajournals.org/doi/10.1161/JAHA.125.043809?doi=10.1161/JAHA.125.043809

Are Patients Game? Investigating the Role of Game Technology ... People living with congenital heart disease (CHD) require lifelong care, but up to 60% discontinue care or are lost during the transition from pediatric to ...

7. withpower.com withpower.com/trial/phase-congenital-heart-disease-in-adolescence-7-2025-0a387

Serious Game for Congenital Heart Disease This small pilot study will evaluate the game's usability, acceptability, and its impact on participants' confidence and preparedness for managing their heart ...